Phase II Trial of Carboplatin and Bevacizumab for Progressive Breast Cancer Brain Metastases
- Participants will receive bevacizumab and carboplatin intravenously. In addition to
bevacizumab and carboplatin, participants whose cancer is positive for HER2 will
receive Herceptin intravenously. Herceptin is a standard treatment for patients with
HER2-positive breast cancer.
- The first treatment cycle lasts four weeks. Participants will receive bevacizumab on
Day 1 and carboplatin on Day 8. After the first treatment cycle, each treatment cycle
thereafter lasts three weeks and participants will receive bevacizumab and carboplatin
together on Day 1 of each cycle.
- Physical exams and vital signs will be performed and collected at multiple time points
during the participants first treatment cycle and at the beginning of each cycle
- Participants will have a brain MRI and MRA between days 2-4 of the first treatment
cycle and again at the end of the second treatment cycle for research purposes only.
These scans are mandatory and must be performed at the Massachusetts General
Hospital-Charlestown Navy Yard facility. A brain MRI will be performed every other
cycle after that (the end of cycles 2, 4, 6, 8, etc.). Participants will also have CT
or MRI scans of their body at the enof of every other treatment cycle.
- MUGA or ECHO scans will be done every 4 treatment cycles.
- Participants will have blood tests done on Day 8 of the first treatment cycle and at
the beginning of every treatment cycle thereafter to check blood cell counts and how
well their organs are functioning.
- A urine test will be done every other cycle (at the beginning of cycles 3, 5, 7, etc.)
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Central nervous system (CNS) objective response, defined as either complete response or partial response
Nancy Lin, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Beth Israel Deaconess Medical Center||Boston, Massachusetts 02215|
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|